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Vagus Nerve Stimulation

Phase 1

Congestive Heart Failure | Unknown | Cardiovascular |LivaNova PLC|Last Updated: Feb 19, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01823887Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) StudyPHASE1 COMPLETED 60 — — Jul 1, 2012Jun 1, 2014Feb 19, 20151 India
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Study Endpoints
Primary Endpoints
Cardiac Function
6 months

Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)

Adverse Events
6 months

Incidence of procedure and device-related complications

Secondary Endpoints
Functional Status
6 months
Quality of Life
6 months
Autonomic Function
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Left Sided StimulationEXPERIMENTALLeft cervical Vagus Nerve Stimulation (VNS)
Right Sided StimulationEXPERIMENTALRight Cervical Vagus Nerve Stimulation (VNS)
Interventions
NameTypeDescription
Vagus Nerve Stimulation (VNS)DEVICEElectrical Stimulation of the Vagus Nerve
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts

Countries:India
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